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Cyclophosphamide

Generic Name
Cyclophosphamide
Brand Names
Procytox
Drug Type
Small Molecule
Chemical Formula
C7H15Cl2N2O2P
CAS Number
50-18-0
Unique Ingredient Identifier
6UXW23996M

Overview

Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent that must be activated in the liver to form the active aldophosphamide. It has been used in the treatment of lymphoma and leukemia. Its side effect, alopecia, has been used for defleecing sheep. Cyclophosphamide may also cause sterility, birth defects, mutations, and cancer.

Indication

Cyclophosphamide is indicated for the treatment of malignant lymphomas, multiple myeloma, leukemias, mycosis fungoides (advanced disease), neuroblastoma (disseminated disease), adenocarcinoma of the ovary, retinoblastoma, and carcinoma of the breast. It is also indicated for the treatment of biopsy-proven minimal change nephrotic syndrome in pediatric patients.

Associated Conditions

  • Acute Lymphoblastic Leukaemias (ALL)
  • Acute Myeloid Leukemia
  • Acute monocytic leukemia
  • Adenocarcinoma of the Ovaries
  • Breast Cancer
  • Burkitt Lymphoma
  • Chronic Lymphocytic Leukemia
  • Chronic Myelogenous Leukemia (CML)
  • Hodgkins Disease (HD)
  • Lung Cancer
  • Lupus
  • Lymphocytic Lymphomas
  • Lymphoma
  • Multiple Myeloma (MM)
  • Multiple Sclerosis
  • Nephrotic syndrome with lesion of minimal change glomerulonephritis
  • Non-Hodgkin's Lymphoma (NHL)
  • Retinoblastoma
  • Advanced Alibert-Bazin syndrome
  • Chronic Granulocytic Leukemias
  • Disseminated Neuroblastoma (NB)
  • Histiocytic lymphoma
  • Mixed-cell type lymphoma

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/07/09
Not Applicable
Not yet recruiting
2025/07/04
Not Applicable
Not yet recruiting
2025/07/01
Not Applicable
Not yet recruiting
PETHEMA Foundation
2025/06/26
Phase 1
Not yet recruiting
2025/06/25
Phase 1
Not yet recruiting
2025/06/24
Phase 2
Not yet recruiting
2025/06/17
Phase 1
Not yet recruiting
Peking University Cancer Hospital & Institute
2025/06/11
Phase 2
Not yet recruiting
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
2025/06/11
Phase 2
Not yet recruiting
Vandana Abramson
2025/06/11
Phase 2
Not yet recruiting
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Baxter Healthcare Corporation
10019-957
INTRAVENOUS, ORAL
2 g in 100 mL
10/25/2014
Baxter Healthcare Corporation
10019-956
INTRAVENOUS, ORAL
1 g in 50 mL
10/25/2014
AuroMedics Pharma LLC
55150-271
INTRAVENOUS
1 g in 5 mL
9/8/2021
STI Pharma LLC
54879-021
ORAL
25 mg in 1 1
1/12/2024
Sandoz Inc.
0781-3233
INTRAVENOUS, ORAL
500 mg in 25 mL
12/22/2021
Civica, Inc.
72572-087
INTRAVENOUS, ORAL
500 mg in 25 mL
7/31/2022
Alembic Pharmaceuticals Inc.
62332-618
ORAL
25 mg in 1 1
2/17/2023
Amneal Pharmaceuticals LLC
70121-1240
INTRAVENOUS, ORAL
2 g in 100 mL
11/3/2023
Long Grove Pharmaceuticals, LLC
81298-8110
INTRAVENOUS, ORAL
500 mg in 25 mL
11/10/2023
NorthStar RxLLC
72603-104
INTRAVENOUS, ORAL
500 mg in 25 mL
10/11/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
ENDOXAN FOR INJECTION 500 mg/vial
SIN01748P
INJECTION, POWDER, FOR SOLUTION
500 mg/vial
6/9/1988
CYCRAM FOR INJECTION 1 g/vial
SIN10355P
INJECTION, POWDER, FOR SOLUTION
1 g/vial
11/3/1998
ENDOXAN TABLET 50 mg
SIN00929P
TABLET, SUGAR COATED
50 mg
5/9/1988
ENDOXAN FOR INJECTION 1 g/vial
SIN01747P
INJECTION, POWDER, FOR SOLUTION
1 g/vial
6/9/1988
ENDOXAN FOR INJECTION 200 mg/vial
SIN00930P
INJECTION, POWDER, FOR SOLUTION
200 mg/vial
5/9/1988

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
Cyclophosphamide Capsules
国药准字H20233047
化学药品
胶囊剂
1/10/2023
Cyclophosphamide Capsules
国药准字H20233046
化学药品
胶囊剂
1/10/2023
Cyclophosphamide for Injection
国药准字H32020856
化学药品
注射剂
8/21/2020
Cyclophosphamide for Injection
国药准字HJ20160468
化学药品
注射剂
6/8/2021
Cyclophosphamide for Injection
国药准字H20093392
化学药品
注射剂
10/10/2023
Cyclophosphamide for Injection
国药准字H20023036
化学药品
注射剂
8/21/2020
Cyclophosphamide for Injection
国药准字H14023686
化学药品
注射剂
8/25/2020
Cyclophosphamide for Injection
国药准字H20244714
化学药品
注射剂
8/20/2024
Cyclophosphamide for Injection
国药准字H32020857
化学药品
注射剂
8/21/2020
Cyclophosphamide for Injection
国药准字H32026196
化学药品
注射剂
8/21/2020

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

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